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Pain Relief - Tramadol Versus Ibuprofen

This study is ongoing, but not recruiting participants.

Sponsored by: Royal Liverpool University Hospital
Information provided by: Royal Liverpool University Hospital
ClinicalTrials.gov Identifier: NCT00111046
  Purpose

The purpose of this study is to assess post operative pain following the insertion of radioactive plaque for choroidal melanoma in patients after receiving either ibuprofen or tramadol.


Condition Intervention Phase
Choroidal Melanoma
Melanoma
Eye Neoplasms
Drug: Ibuprofen
Drug: Tramadol
Phase I
Phase II

Genetics Home Reference related topics:   retinoblastoma   

MedlinePlus related topics:   Cancer    Eye Cancer    Melanoma   

ChemIDplus related topics:   Ibuprofen    Dexibuprofen    Tramadol hydrochloride    Tramadol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Post-Operative Pain Relief Following Insertion of Radioactive Plaque for Choroidal Melanoma: Randomised Control Trial of Tramadol Vs Ibuprofen: A Pilot Study

Further study details as provided by Royal Liverpool University Hospital:

Primary Outcome Measures:
  • Compare levels of pain

Estimated Enrollment:   40
Study Start Date:   February 2001
Estimated Study Completion Date:   February 2004

Detailed Description:

Patients with choroidal melanomas who are offered ruthenium plaque radiotherapy have their plaque sutured to the sclera under general anaesthesia. The plaque is removed in a few days after delivering the required radioactive dosage to the tumour. While the plaque is in situ, patients require analgesia. The management of post-operative pain is generally not considered a high priority, more importance being given to the regression of the melanoma.

This is indicated by the lack of any study addressing this aspect of care. The failure of patients in general, to complain, may perhaps be due to them having accepted that some degree of pain following 'major surgery for a malignant ocular condition' is the norm.

As per current protocol, ibuprofen is being prescribed, unless contraindicated. Although many are comfortable, others request additional analgesics. Most opioid analgesics provide better pain relief but are associated with nausea, vomiting, constipation and respiratory depression.

Tramadol is an opioid analgesic that is reported to have less of the above mentioned side affects.

Comparisons: To compare the analgesic effect of oral tramadol versus ibuprofen in such patients.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • All patients that are admitted for undergoing plaque radiotherapy for choroidal melanoma would be approached to participate in this study.
  • They should be adults who are of a sound frame of mind to give an informed consent to participate.

Exclusion Criteria:

  • Patients less than 18 years of age
  • Patients of unsound mind not capable of giving informed consent
  • Active peptic ulcer disease, asthma, renal dysfunction, warfarin therapy, hypothyroidism history of epilepsy, pregnancy, breastfeeding and hypersensitivity to either products.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111046

Locations
United Kingdom, Merseyside
Royal Liverpool University Hospital    
      Liverpool, Merseyside, United Kingdom, L8 0RU

Sponsors and Collaborators
Royal Liverpool University Hospital

Investigators
Principal Investigator:     Bertil Damato     Royal Liverpool University Hospital    
  More Information


Study ID Numbers:   2K/261, R&D 1931
First Received:   May 16, 2005
Last Updated:   November 9, 2005
ClinicalTrials.gov Identifier:   NCT00111046
Health Authority:   United Kingdom: National Health Service

Keywords provided by Royal Liverpool University Hospital:
Pain Relief  
Choroidal melanoma  
plaque radiotherapy  

Study placed in the following topic categories:
Ibuprofen
Eye Neoplasms
Tramadol
Eye Diseases
Pain
Melanoma
Neuroendocrine Tumors
Melanoma of the choroid
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Neuroepithelioma
Nevus
Pain, Postoperative

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Nevi and Melanomas
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on September 15, 2008




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